Trial Outcomes & Findings for Passive Disinfection Cap Compliance Study (NCT NCT03391960)

Results Overview

Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

165 participants

Primary outcome timeframe

6-month prospective period

Results posted on

2024-10-02

Participant Flow

No individual patient was recruited into the study.

Unit of analysis: Compliance audits

Participant milestones

Participant milestones
Measure	Compliance With Scrub the Hub Protocol Compliance with scrub the hub protocol was retrospectively measured through a survey from Health care workers who were working in the hospital and used needleless connector	Compliance With Disinfecting Barrier Cap Ptotocol In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.
Overall Study STARTED	165 0	0 156
Overall Study COMPLETED	165 0	0 156
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Compliance With Scrub the Hub Protocol Compliance with scrub the hub protocol was retrospectively measured through a survey from Health care workers who were working in the hospital and used needleless connector	Compliance With Disinfecting Barrier Cap Ptotocol In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.
Overall Study Protocol Violation	0	0

Baseline Characteristics

Passive Disinfection Cap Compliance Study

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 6-month prospective period

Population: No patients assessed for disinfecting barrier cap compliance. Compliance with disinfecting barrier cap was measured by observation of numbers of applicable capped, uncapped ports and misused caps. A total of 156 audits were performed.

Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage.

Outcome measures

Outcome measures
Measure	Disinfecting Barrier Cap Compliance n=156 Compliance audits In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.	CLABSI Rate for Post-intervention Period Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
Disinfecting Barrier Cap Compliance	98.43 percentage of connector with compliance Standard Deviation 4.18	—

PRIMARY outcome

Timeframe: 6-month retrospective period

Population: Compliance with scrub the hub was retrospectively obtained by a survey from 165 healthcare workers who were using needlessness connectors for patient IV access. One was excluded from the compliance analysis due to an inconsistency in the survey data. No patients assessed for disinfecting barrier cap compliance.

Compliance with Scrub the hub protocol Data collected retrospectively by survey

Outcome measures

Outcome measures
Measure	Disinfecting Barrier Cap Compliance n=164 Participants In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.	CLABSI Rate for Post-intervention Period Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
Scrub the Hub Protocol Compliance	5.95 percentage of protocol compliance Standard Deviation 21.36	—

SECONDARY outcome

Timeframe: 6-month retrospective period and 6-month prospective period

Population: Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.

Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments to determine the CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access

Outcome measures

Outcome measures
Measure	Disinfecting Barrier Cap Compliance n=36 ICU and non-ICU wards In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.	CLABSI Rate for Post-intervention Period n=36 ICU and non-ICU wards Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
CLABSI Rate	2.9 CLABSI rate per 1000 catheter days	3.2 CLABSI rate per 1000 catheter days

SECONDARY outcome

Timeframe: 6 months pre-intervention and 6 months post intervention

Population: Infections from patients with indwelling urinary catheters in one ICU ward. Total 6 units. No individual patients were enrolled in this study. No patients assessed for this measure.

Rate of CAUTI per 1000 indwelling urinary catheter days. CAUTI data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of CAUTI is only mandatory in the intensive care setting in Brazil.

Outcome measures

Outcome measures
Measure	Disinfecting Barrier Cap Compliance n=6 Units in ICU ward In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.	CLABSI Rate for Post-intervention Period n=6 Units in ICU ward Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
Catheter-associated Urinary Tract Infection (CAUTI) Rate	0.78 CAUTI rate per 1000 catheter days	2.26 CAUTI rate per 1000 catheter days

SECONDARY outcome

Timeframe: 6-month retrospective period and 6-month prospective period

Population: Infections from patients who have been intubated and received mechanical ventilation in one ICU ward (6 units). No Patients assessed for this measure.

Rate of VAP per 1000 ventilator days. VAP data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of VAP is only mandatory in the intensive care setting in Brazil.

Outcome measures

Outcome measures
Measure	Disinfecting Barrier Cap Compliance n=6 Units in ICU ward In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.	CLABSI Rate for Post-intervention Period n=6 Units in ICU ward Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
Ventilator-associated Pneumonia (VAP) Rate	6.2 VAP rate per 1000 ventilator days	5.35 VAP rate per 1000 ventilator days

SECONDARY outcome

Timeframe: 6-month retrospective period and 6-month prospective period

Population: Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.

Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. MBI-related CLABSIs and CVC/day were used to determine MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access.

Outcome measures

Outcome measures
Measure	Disinfecting Barrier Cap Compliance n=36 ICU and non-ICU wards In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.	CLABSI Rate for Post-intervention Period n=36 ICU and non-ICU wards Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
MBI-Related CLABSI Rate	1 MBI CLABSI rate per 1000 catheter days	1.28 MBI CLABSI rate per 1000 catheter days

SECONDARY outcome

Timeframe: 6-month retrospective period and 6-month prospective period

Population: Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.

Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. Non MBI-related CLABSIs and CVC/day were used to determine Non-MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access.

Outcome measures

Outcome measures
Measure	Disinfecting Barrier Cap Compliance n=36 ICU and non-ICU wards In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.	CLABSI Rate for Post-intervention Period n=36 ICU and non-ICU wards Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
Non MBI-related CLABSI Rate	1.93 CLABSI rate per 1000 catheter days	1.92 CLABSI rate per 1000 catheter days

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Helen Han

3M

Phone: 651-737-9234

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60